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NeuroShield

FDA UDI

Class II (US FDA UDI)

by Monarch Bioimplants GmbH

Identity

Trade Name
NeuroShield FDA UDI
Generic Name
Nerve guide, animal-derived FDA UDI
Device Name
NeuroShield® is a chitosan polysaccharide film indicated for the repair of peripheral nerve injuries by providing a protective barrierduring tissue healing. FDA UDI
Model / Reference
NS3020 FDA UDI
Description
NeuroShield® is a chitosan polysaccharide film indicated for the repair of peripheral nerve injuries by providing a protective barrierduring tissue healing. FDA UDI

Identifiers

Primary DI / UDI-DI
07640181711017 FDA UDI
510(k) Number
K190246 FDA UDI
FDA Product Code
JXI FDA UDI
GMDN Term
Nerve guide, animal-derived FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5275 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Nerve guide, animal-derived

NeuroShield by Monarch Bioimplants GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nerve guide, animal-derived.

Cleared under the same submission

K190246 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Monarch Bioimplants GmbH

Sources (1)

  • FDA UDI 919ef7ab-b93a-416d-b859-56da9f553c81 36 fields · synced May 30, 2026